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NCT04563039 · ClinicalTrials.gov registry record · NA
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
A NA study of Urinary Stones, sponsored by Avvio Medical.
- Completed
- Registry status
- NA
- Development phase
- 196
- Enrollment target
- 20
- Study locations
NCT04563039: Completed NA study of Urinary Stones, sponsored by Avvio Medical.
NCT04563039 is a NA study of Urinary Stones that has completed, run by Avvio Medical. The registered enrollment target is 196 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04563039, a NA study of Urinary Stones, has completed, sponsored by Avvio Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 196 participants
- Enrollment target
- 20
- Study locations
Study Summary
A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
Primary Outcome
Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging
Conditions Studied
Interventions
- DEVICE Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
- DEVICE Standard Ureteroscopic Laser Lithotripsy
Study Locations (20)
California
- University of California - Irvine
- University of California - San Diego
- University of California - San Francisco
Florida
- University of Florida - Gainesville
- University of Miami Health - Miami
Kansas
- University of Kansas Medical Center - Kansas City
- Wichita Urology Group - Wichita
New York
- Mount Sinai West - New York
- SUNY Upstate Medical University - Syracuse
Pennsylvania
- MidLantic Urology - Bala-Cynwyd
- Penn State Milton S. Hershey Medical Center - Hershey
Alabama
- University of Alabama - Birmingham
Arizona
- Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC) - Tucson
Arkansas
- Arkansas Urology Research Center - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2023-07-30 |
| Phase | NA |
What the finished NCT04563039 record still lists
NCT04563039 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Urinary Stones appearing as the primary indexed condition, and to 2 interventions - of which Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer is the first listed.
NCT04563039 names 20 study sites across 14 states, led by California, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT04563039 about?
NCT04563039 is a clinical study titled "Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)". A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
What is the current status of trial NCT04563039?
This trial is currently completed. It is a NA study. The enrollment target is 196 participants. The study started on 2021-05-21. Estimated completion is 2023-07-30.
What conditions does trial NCT04563039 study?
This clinical trial studies the following conditions: Urinary Stones.
What interventions are being tested in trial NCT04563039?
The interventions under investigation include: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer (DEVICE), Standard Ureteroscopic Laser Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT04563039?
This trial is sponsored by Avvio Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04563039 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04563039's enrollment target sits among peer trials
196 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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